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Population Pharmacokinetics of Amoxicillin in Neonates (NEOPOPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03987100
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

The objective of NEOPOPI is to conduct a population pharmacokinetic study of amoxicillin in neonates, in order to evaluate and optimize neonatal dose regimen.

There will be no change to the medication treatment received by participants. An opportunistic pharmacokinetic sampling approach will be followed: samples will be scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this way, no additional invasive tests will be needed.

Condition or disease

Detailed Description:
  • Administration of the antibiotic according to the usual procedures for prescribing services: in particular, neither the indications nor the doses nor the methods of administration are fixed by the protocol
  • Opportunistic sampling strategy: no biological samples are specifically collected for the purposes of the study (measurements of concentrations on "bottoms" or "left-over" samples); the performance of this non-invasive sampling strategy has been previously demonstrated in the neonatal population.
  • Micro-analytical method (assay of concentrations on micro-volumes, of the order of 50μL)
  • Population pharmacokinetic analysis

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Population Pharmacokinetics of Amoxicillin in Neonates: Evaluation and Optimization of the Dose
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Primary Outcome Measures :
  1. Achievement rate of therapeutic efficacy target of amoxicillin [ Time Frame: 1 week ]
    Achievement rate of therapeutic efficacy target of amoxicillin (ie percentage of neonates in whom amoxicillin plasma concentration remains above the MIC of target organisms for more than 70% of the dose range). In accordance with the recommendations of the European Medicines Agency, the optimal dosage regimen is defined as leading to a probability of antibiotic therapy success of greater than or equal to 90%. Thus, it is necessary to determine the dosage regimen allowing the target of therapeutic efficacy to be reached (ie maintenance of the plasma concentration of amoxicillin greater than the MIC of the targeted microorganisms for more than 70% of the dose) in at least 90% of treated neonates.

Secondary Outcome Measures :
  1. Recording of Adverse Events [ Time Frame: 1 week ]
    Recording of adverse events (clinical and / or biological) during the treatment period and up to 96 hours after the end of treatment

  2. Minimum Inhibitory Concentration [ Time Frame: 1 week ]
    Collection of MICs of amoxicillin for isolated germs. For amoxicillin the antibacterial activity is time-dependent, the predictor of efficacy is the "Time> MIC": this is the percentage of the administration interval during which the concentration of the antibiotic remains higher than the MIC of target germs

  3. Concentration of amoxicilin in Cerebrospinal Fluid (CSF) [ Time Frame: 1 week ]
    Calculation of amoxicillin concentration in CSF / amoxicillin plasma concentration when data permits (i.e. when lumbar puncture is performed as part of usual care, during treatment with amoxicillin

Biospecimen Retention:   Samples Without DNA
Blood or cerebrospinal fluid drawn for routine biochemical tests

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 44 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates (including both preterm and full-term neonates) receiving amoxicillin as part of their routine clinical care (for suspected or proven neonatal sepsis).

Inclusion Criteria:

  • Neonates receiving amoxicillin and blood/CSF tests during amoxicillin treatment, as part of their routine clinical care
  • No parental opposition to the study participation

Exclusion Criteria:

• None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03987100

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Contact: Stuart Byrom 0033 (0)299284312
Contact: Stephanie Leroux, Phd 0033 (0)299284312

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CHU Rennes Recruiting
Rennes, France, 35000
Contact: Stuart Byrom    0033 (0)299284312   
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital Identifier: NCT03987100    
Other Study ID Numbers: 35RC18-9874
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes